Suzan Onel

Latest Publications

Between January 20 and February 9, 2015, the U.S. Food and Drug Administration (“FDA”) issued four guidances related to its policies toward low risk devices. These guidances were largely developed as an outgrowth from FDA’s...more

Welcome -
We are pleased to provide you with the Fall edition of the Global Food, Drugs, Medical Devices and Cosmetics newsletter. This newsletter provides updates on important issues and developments across these...more

Welcome -
We are pleased to provide you with the Spring edition of the Global Food, Drugs, Medical Devices and Cosmetics newsletter. As stated in our inaugural issue, this newsletter provides updates on important...more

Introduction -
The Patient Protection and Affordable Care Act (“ACA”) generates very few areas of agreement. However, in recent months, proposals to repeal one of the most visible and controversial provisions of the...more

I. Introduction -
If you represent food and beverage manufacturers who advertise their products, you will want to be familiar with In the Matter of POM Wonderful LLC, a recent decision by the Federal Trade Commission...more

On December 3, 2012, a divided Second Circuit held in United States v. Caronia (“Caronia”) that the misbranding provisions of the Federal Food, Drug, and Cosmetic Act (“FDCA”) do not criminalize “the truthful off-label...more

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